Kaletra: Therapy With Double Protease Inhibitors

PMOS: Kaletra Double Protease Inhibitors

Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus

Detailed Description

This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10439
    • Site Reference ID/Investigator# 48283
  • Berlin, Germany, 10551
    • Site Reference ID/Investigator# 28131
  • Berlin, Germany, 10961
    • Site Reference ID/Investigator# 66422
  • Berlin, Germany, 13347
    • Site Reference ID/Investigator# 28123
  • Berlin, Germany, D-10243
    • Site Reference ID/Investigator# 28109
  • Dortmund, Germany, 44137
    • Site Reference ID/Investigator# 28115
  • Frankfurt, Germany, 60311
    • Site Reference ID/Investigator# 28124
  • Frankfurt, Germany, 60329
    • Site Reference ID/Investigator# 28127
  • Frankfurt, Germany, 60596
    • Site Reference ID/Investigator# 28119
  • Krefeld, Germany, 47800
    • Site Reference ID/Investigator# 5318
  • Ludwigshafen, Germany, 67063
    • Site Reference ID/Investigator# 28112
  • Muenster, Germany, 48143
    • Site Reference ID/Investigator# 28111
  • Muenster, Germany, 48149
    • Site Reference ID/Investigator# 28129
  • Munich, Germany, 80337
    • Site Reference ID/Investigator# 28118
  • Munich, Germany, 80801
    • Site Reference ID/Investigator# 28113
  • Stuttgart, Germany, 70197
    • Site Reference ID/Investigator# 28133
  • Wuppertal, Germany, 42277
    • Site Reference ID/Investigator# 28126

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample; Human Immunodeficiency Virus-infected participants

Description

Inclusion Criteria:

• Participants with Human Immunodeficiency Virus infection
• Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor

Exclusion Criteria:

• Hypersensitivity against lopinavir, ritonavir or other ingredients
• Severe liver insufficiency
• No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HIV-infected participants; HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL	Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Absolute CD4 Cell Count	Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in Relative CD4 Cell Count	Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in Absolute CD8 Cell Count	Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in Relative CD8 Cell Count	Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Change From Baseline in CD4/CD8 T-cell Ratio	The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.	Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: Stefan Simianer, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: February 23, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 25, 2010

Study Record Updates

• Last Update Posted (Estimate): January 18, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Infection; Human Immunodeficiency Virus; Resistance; Viral load; Double protease inhibitors; Mutations; Immune system; Nucleoside Reverse Transcriptase Inhibitors-free
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: P05-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No